METHODS FOR QUANTITATIVE DETERMINATION OF POLYPEPTIDES Russian patent published in 2022 - IPC G01N33/68 

FIELD: biotechnology; biochemistry.

SUBSTANCE: invention relates to the field of biotechnology and biochemistry, specifically to a method for quantitative determination of content of polypeptide containing a section of a constant region of a heavy chain of an antibody in a sample, using mass-spectrometry. The method for quantitative determination of content of polypeptide includes (a) cleavage of the sample containing polypeptide including the section of the constant region of the heavy chain of the antibody, containing a structured mutation, where, as a result of cleavage, a peptide fragment is formed, obtained from the constant region of the heavy chain of the antibody, which has a length from 5 to 26 amino acids and contains a structured mutation; and (b) analysis of the cleaved sample by mass-spectrometry for determination of amount of the peptide fragment, thereby determining amount of polypeptide containing the section of the constant region of the heavy chain of the antibody in the sample.

EFFECT: specified method can be used for quantitative determination of therapeutic proteins both in samples in preclinical studies (i.e., obtained from animal species) and in samples in clinical studies (i.e., obtained from human patients).

40 cl, 22 dwg, 8 tbl, 4 ex